Resources Library

From GCP to GVP Whitepaper: A Pharmacovigilance Guide for Emerging Biotech Firms Transitioning from clinical development to post-marketing represents a critical phase for emerging biotech companies, demanding the establishment of robust pharmacovigilance (PV) systems. Given the resource and expertise constraints often faced by smaller biotech firms, outsourcing to Contract Research Organizations (CROs) emerges as a viable solution. However, this approach introduces its own set of challenges, including maintaining control, ensuring quality, and managing flexibility. This whitepaper explores strategic considerations and practical steps to optimize PV activities outsourcing. It aims to guide biotech executives through the challenges of selecting operating models that align with their company’s objectives, regulatory demands, and market dynamics. The paper discusses the balance between leveraging external expertise and retaining crucial oversight of PV operations.

Challenging Early-Stage Fundraising Environment Requires a Change in Thinking Biotechs setting out on their fundraising journey will benefit from thinking deeply about the most appropriate indications for their assets. Indication Prioritization is a key first step in this process, requiring a holistic assessment of possible disease areas relevant to and asset’s mechanism of action in relation to the biology of the disease. This exercise is best done using a comparative scoring system personalized to the specific needs of each client, which allows a relatively objective decision to be made on the optimal disease and population in which to develop an asset. Indication Prioritization involves performing a deep dive into the literature, clinical trial results and underlying data in order to produce a landscape assessment for each indication. This blog discusses Adnovate's approach to Indication Prioritization and its value in drug development.